Nivolumab in the Real World in Patients With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 509
- 试验地点
- 1
- 主要终点
- Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth
研究概览
简要总结
The purpose of the study is to capture the utilization of nivolumab among participants with squamous cell carcinoma of the head and neck (SCCHN) since its approval, and to describe the health related quality of life (HRQoL) among participants treated with nivolumab in a real-world setting.
详细描述
This is a phase 4 prospective chart review study with patient reported outcome (PRO) administration. The study population consists of participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) and are being treated with nivolumab. Eligible participants will be enrolled and observed from enrollment up to eight weeks. Demographic and clinical characteristics will be collected at enrollment. PROs will be administered at enrollment and again at a follow-up standard of care visit approximately eight weeks after enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN)
- •Age ≥18 years at time of nivolumab treatment initiation
- •Investigator has decided that nivolumab is appropriate therapy and the participant had received at least one administration of nivolumab for the treatment of recurrent/metastatic SCCHN prior to enrolment in the study
- •Charts/records include treatment start date of nivolumab
- •Provide consent and is willing to self-complete on-site patient reported outcomes (PROs) on at least one occasion
排除标准
- •Currently enrolled in an interventional clinical trial for their SCCHN
- •Received systemic treatment for any other primary cancer within 6 months of study enrolment
结局指标
主要结局
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth
时间窗: At enrollment
Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head \& Neck (SCCHN)
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex
时间窗: At enrollment
Distribution of patient reported HRQoL measures through CTSQ in participants treated with nivolumab for R/M SCCHN
时间窗: At enrollment, Up to 8 weeks
Cancer Therapy Satisfaction Questionnaire (CTSQ)
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status
时间窗: At enrollment
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity
时间窗: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location
时间窗: At enrollment
Distribution of patient reported health-related quality of life (HRQoL) measures through European Organisation for Research and Treatment of Cancer Quality of Life- Core Questionnaire in participants treated with nivolumab for R/M SCCHN
时间窗: At enrollment, Up to 8 weeks
Distribution of patient reported HRQoL measures through European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module in participants treated with nivolumab for R/M SCCHN
时间窗: At enrollment, Up to 8 weeks
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations
时间窗: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis
时间窗: At enrollment
Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy
时间窗: Up to 8 weeks following enrollment
Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation
时间窗: Up to 8 weeks following enrollment
Distribution of subsequent treatment in participants discontinuing nivolumab
时间窗: Up to 8 weeks following enrollment
Distribution of patient reported HRQoL measures through EQ-5D-5L in participants treated with nivolumab for R/M SCCHN
时间窗: At enrollment, Up to 8 weeks
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology
时间窗: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN
时间窗: At enrollment
Distribution of doses of nivolumab therapy in participants with R/M SCCHN
时间窗: Up to 8 weeks following enrollment
Distribution of patient reported HRQoL measures through WPAI:GH in participants treated with nivolumab for R/M SCCHN
时间窗: At enrollment, Up to 8 weeks
Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)
次要结局
未报告次要终点